Petaling Jaya, Selangor, Malaysia · On-site
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other C…
Skills: Clinical Monitoring, ICH-GCP Compliance, Site Management, Source Data Verification, Case Report Form Review
Mont-Saint-Guibert, Wallonia, Belgium · On-site
Bioinformatician – Discovery Are you ready to dive into the world of transformative therapies and make a significant impact? At EsoBiotec, now part of AstraZeneca, we are setting new benchmarks for biotechnological resea…
Skills: Bioinformatics, R, Python, Statistical Analysis, Data Visualization
Gaithersburg, Maryland, United States · Hybrid
$186k–$279k/yr
Job Description Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metab…
Skills: Regulatory Strategy, Drug Development, Health Authority Interaction, Clinical Strategy, Life Cycle Management
Gaithersburg, Maryland, United States · On-site
$169k–$253k/yr
AstraZeneca has a longstanding heritage in developing vaccines and antibody therapies that have contributed to global disease prevention and the advancement of immunisation strategies. AstraZeneca’s Vaccines & Immune The…
Skills: Corporate Affairs Strategy, Public Policy, Patient Advocacy, External Communications, Stakeholder Management
Boston, Massachusetts, United States · Hybrid
$186k–$279k/yr
Job Description Are you passionate about science and experienced within regulatory affairs and drug development? Do you possess strategic and operational leadership skills? Then, join us at Cardiovascular, Renal or Metab…
Skills: Regulatory Strategy, Drug Development, Health Authority Interaction, Clinical Strategy, Life Cycle Management
Special capital Region of Jakarta, Java, Indonesia · On-site
Supply Planning & Distribution Associate Director Do you have expertise in supply planning and distribution? Would you like to apply your expertise to help deliver life-changing medicines in an organization that follows …
Skills: Supply Planning, Distribution Management, Distributor Network Strategy, S&OP, IBP
China · On-site
Typical Accountabilities - Lead the District Team to achieve or surpass predetermined sales forecasts and call execution objectives, ensuring alignment with company sales strategies. - Collaborate with individual sales r…
Skills: Sales Leadership, Financial Management, Interpersonal Communication, Strategic Problem Solving, Talent Development
Macclesfield, England, United Kingdom · Hybrid
Regional Digital Project and Change Manager Location: Macclesfield, UK At AstraZeneca, science compels us to push the boundaries of what is possible to turn science into life-changing medicines for patients who need them…
Skills: Business Analysis, Stakeholder Management, Agile Methodology, Lean Methodologies, Project Management
Athlone, Leinster, Ireland · On-site
Introduction to role: Are you ready to keep GMP-critical utilities running flawlessly so life-changing medicines reach patients without interruption? As a Utility Engineer based at our Athlone manufacturing site, you wil…
Skills: GMP Compliance, Utility Engineering, Root Cause Analysis, CMMS, BMS/MCS
Mississauga, Ontario, Canada · On-site
$109k–$143k/yr
Senior Statistician II, Late Oncology Introduction to role Are you ready to turn complex data into decisions that shape late-stage oncology development? Do you want your statistical judgment to be visible at the moments …
Skills: Study Design, Statistical Analysis Plans, Modelling and Simulation, Late-stage Oncology Trials, SAS
Macclesfield, England, United Kingdom · Hybrid
Job Title: Head of Make CoE Location: Macclesfield Hybrid Working: Minimum 3 days per week in the office Introduction to role: Are you ready to shape the future of how we make life-changing medicines across a global manu…
Skills: Pharmaceutical Operations, Business Process Management, Strategic Planning, Stakeholder Management, Digital Manufacturing
Warsaw, Masovian Voivodeship, Poland · Hybrid
Reward Lead, Poland Location: Warsaw, hybrid work (3days from the office per week) At AstraZeneca, we are not afraid to do things differently. We are building a new kind of organisation to reset expectations of what a bi…
Skills: Compensation and Benefits, Total Reward Strategy, Stakeholder Management, Vendor Management, Polish Labour Market Knowledge
Dublin, Leinster, Ireland · On-site
Job Title: Governance and Ethics Lead Location: Dublin Competitive salary and benefits Introduction to role: Are you ready to shape governance that enables responsible innovation while protecting patients, our reputation…
Skills: Governance, Ethics, Compliance, Risk Mitigation, Signatory Approval
Dubai, Dubai, United Arab Emirates · On-site
JOB TITLE Diagnostic Science Liaison, Oncology ABOUT ASTRAZENECA AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescr…
Skills: Precision Oncology, Biomarker Testing, Molecular Diagnostics, Stakeholder Management, Scientific Exchange
Mississauga, Ontario, Canada · Hybrid
$135k–$177k/yr
When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform to connect, work at pace and challenge perceptions. That’…
Skills: Hypothesis Testing, Predictive Modeling, Survival Analysis, Time-series Forecasting, Causal Inference
Hamilton, Ontario, Canada · On-site
$133k–$175k/yr
Job Title: Contracts Manager Location: Hamilton, Ontario Onsite 5 days/week Description: Fusion Pharmaceuticals, part of the AstraZeneca Group, is redefining precision oncology with next‑generation radioconjugates that d…
Skills: Contract Review, Contract Negotiation, Risk Identification, Regulatory Compliance, Document Management
Wilmington, Delaware, United States · On-site
$194k–$291k/yr
About the Role AstraZeneca is seeking a Marketing Director, Consumer to lead the consumer marketing strategy for BREZTRI, our inhaled respiratory therapy for COPD and Asthma. In this role you will own the consumer brand …
Skills: Consumer Marketing Strategy, Omnichannel Campaign Development, Direct-to-Consumer (DTC), Patient Acquisition, Budget Management
Durham, North Carolina, United States · Hybrid
Location: Winchester Place, Durham, North Carolina, United States Working model: Office-based / hybrid, with an expectation to work from the office on average a minimum of three days per week Function: Operational Data S…
Skills: Business Analytics, Strategy, Portfolio Management, Power BI, DAX
Dublin, Leinster, Ireland · On-site
Position Summary: The QA Manager will be responsible for the oversight of operational quality activities associated with the packaging and disposition of commercial and clinical finished products at the Alexion College P…
Skills: Quality Management, cGMP Compliance, Team Leadership, QMS Oversight, Batch Release
Wilmington, Delaware, United States · On-site
$195k–$292k/yr
Join the Biopharmaceuticals Business Unit at AstraZeneca as a US Tozorakimab (Respiratory Biologics) Insight Director. This role is based in our US Respiratory Insight, Analytics, and Forecasting team and will lead the g…
Skills: Market Research, Competitive Intelligence, Forecasting, Data Analytics, Strategic Thinking
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
The CRA is responsible for the initiation, monitoring, and closure of clinical study sites to ensure compliance with international guidelines and company procedures. They act as the primary contact for study sites, managing data quality, site performance, and regulatory documentation.
Candidates must have experience in clinical research monitoring and a strong understanding of ICH-GCP and local regulatory requirements. The role requires the ability to manage site relationships, perform data verification, and ensure inspection readiness.
The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The CRA works in close collaboration with other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study commitments are achieved in a timely and efficient manner. The CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery of the study.
The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with AZ Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
A CRA with longer tenure and experience may take on additional responsibilities that include additional tasks associated with LSAD.
CRAs might have different internal titles based on the experience level (CRA, Senior CRA). The experience level depends on the years of experience, performance record, level of independence in the role, ability to take on additional tasks or tutor more junior colleagues. The Director, Country Head may assign this internal title after confirmation with Senior Director, Cluster Head or Executive Director, Regional Head).
Accountabilities
• Contributes to the selection of potential investigators.
• In some countries, as required, CRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.
• Trains, supports and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principles.
• Confirms that site staff have completed and documented the required trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all times.
• Actively participates in Local Study Team (LST) meetings.
• Contributes to National Investigators meetings, as applicable.
• Initiates, monitors and closes study sites in compliance with AZ Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LST.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
We're transforming the future of healthcare by unlocking the power of what science can do for people, society and the planet. For more information, visit www.astrazeneca.com. Community Guidelines: bit.ly/2MgAcio
Offices: 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, Cambridgeshire CB2 0AA, GB · Astraallen, Sodertalje, Stockholm County 152 57, SE
